What ICH S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals requires
ICH S5(R3) mandates species-specific DART study designs for all new human pharmaceuticals, requiring fertility, embryo-fetal development, and pre/postnatal development studies, with extended one-generation reproductive toxicity studies triggered by endocrine disruption alerts or regulatory requirements aligned to OECD TG 443.
Pillar: Biotech & Genomics · Authority: ICH Safety Working Party (SWP) - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 3.0.0 · Last updated:
Primary source: https://www.ich.org/products/guidelines/safety/safety-single/article/s5.html
SHA-256 integrity: 045e47dc72f59e76ddd5fda470b3b4539eee8b7a3e76f8bd51d160f8984a02d6
Primary Citations — 7 traced to source
- {"title":"ICH S5(R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals - Step 4 Final Guideline","url":"https://database.ich.org/sites/default/files/S5-R3_Guideline_Step4_2020_1117.pdf","instrument":"ICH S5(R3) Step 4 (November 2020)","authority":"International Council for Harmonisation (ICH)"}
- {"title":"ICH S5(R3) Guideline Landing Page","url":"https://www.ich.org/products/guidelines/safety/safety-single/article/s5.html","instrument":"ICH S5(R3)","authority":"ICH"}
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